Stoma Cap Device for Ostomy Maintenance Assistance

ABSTRACT

Provided is a cap device for home use to temporarily cover the stoma resulting from a urostomy, colostomy or ileostomy procedure. It provides a favorable means of preventing leakage during routine cleaning around the stoma during the ostomy pouch replacement process. The device may include, in any combination, use of a flexible elastomeric material for creating low suction to assist with retention, a shaped lip for comfort and sealing, a disposable liner, or internal absorption material to help avoid spillage and leakage.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims an invention which was disclosed in ProvisionalApplication Number 61120468, filed Dec. 7, 2008, entitled “Stoma CapDevice for Ostomy Maintenance Assistance”. The benefit under 35USC§119(e) of the United States provisional application is herebyclaimed, and the aforementioned application is hereby incorporatedherein by reference.

REFERENCES CITED

U.S. Pat. No. 3,958,556U.S. Pat. No. 4,258,704U.S. Pat. No. 4,950,223U.S. Pat. No. 5,045,052U.S. Pat. No. 5,090,424U.S. Pat. No. 5,125,916U.S. Pat. No. 6,569,081U.S. Pat. No. 7,258,661

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable

REFERENCE TO SEQUENCE LISTING, A TABLE, OR A COMPUTER PROGRAM LISTINGCOMPACT DISK APPENDIX

Not Applicable

BACKGROUND OF THE INVENTION

The subject matter is in the medical field of devices for home care use.It helps prevent leakage of effluent from the stoma during the cleaningand pouch replacement processes associated with an ostomy. An ostomyprocedure is necessary to produce an alternate outlet for waste from thebody when the normal path is damaged or must be avoided for medicalreasons. This new outlet is a portal constructed of the patient's ownbody tissue, presenting an opening called a stoma. The stoma typicallyhas a rim approximately one inch in diameter slightly protruding fromthe abdomen. Being constructed of internal tissue, it is vulnerable toabrasion injury. Normal effluent is collected in a pouch applianceadhesively attached to the skin around the stoma. In someconfigurations, the pouch may be detachable from a pouch-holdercomponent, called a flange, which is adhesively attached to the skin.The collection pouch may be emptied multiple times by such detachment orthrough a valved outlet portion of the pouch.

Periodically, with an interval usually in the 3- to 5-day range, theflange and pouch adhesive interface must be replaced. For applianceswith the detachable pouch, such renewal typically involves the followingsteps:

-   -   Remove the old flange and pouch,    -   clean an dry the skin around the stoma where the adhesive        interface will contact it,    -   apply a new layer of protective skin barrier and allow it to        become tacky,    -   attach a new adhesive flange to peristoma area, and    -   attach a new pouch.        For one-piece pouch appliances, the procedure is similar except        for the separate removal and replacement of the flange.

During this replacement process, effluent continues to leak from thestoma and must be collected or prevented from interfering with thetasks. Furthermore, if the peristoma area is not dry when applying theadhesive component, the adhesive will not hold securely, and/or the skinmay become irritated and erode with time.

Previous methods to prevent leakage such as those described in U.S. Pat.No. 3,958,556, U.S. Pat. No. 4,258,704, U.S. Pat. No. 4,950,223, U.S.Pat. No. 5,045,052, U.S. Pat. No. 5,090,424, U.S. Pat. No. 5,125,916,U.S. Pat. No. 6,569,081, and U.S. Pat. No. 7,258,661, for instance,involve the less desirable process of inserting something into thestoma.

Other previous methods known to have been suggested by medicalprofessionals to mitigate consequences of leakage include physicalobstruction by hand with non-purpose designed objects lacking sealingsurfaces, other forms of plugging with penetrating objects, or frequentmechanical wiping, all options with less effectiveness, comfort, ordesirability than the current invention.

BRIEF SUMMARY OF THE INVENTION

The subject item, referred to as the Stoma Cap, is a device suitable fortemporarily capping a stoma resulting from urostomy, colostomy andileostomy procedures, to assist in their maintenance processes for shortperiods during pouch replacement procedures, described in BACKGROUND OFTHE INVENTION, by collecting effluent leakage that would interfere withthose procedures.

The Stoma Cap provides a method of stopping stoma leakage duringcleaning procedures without requiring any penetration of the stoma hole,and it can be left in place through the step of applying the adhesivelyattached flange, ensuring maintained cleanliness. Some embodiments mayfacilitate hands-free usage. Further, it is easy to work around thedevice to perform the procedures described in BACKGROUND OF THEINVENTION. Its smooth opening edge is comfortable and makes a good sealwithout a lot of pressure. In some embodiments, the Stoma Cap can beapplied with a small amount of suction to help keep it in place and makean even better seal. It may be used with hand pressure in cases wherevacuum seal is not maintained or desired, and it may be augmented withadhesive or sealing lubricant. It can be loosely packed with absorbentmaterial to absorb the collected effluent and keep it from spilling whenthe Stoma Cap is removed. It can be easily cleaned after each use, andnon-disposable embodiments can be easily sterilized before each use. Itis inexpensive.

An example embodiment of the Stoma Cap consists of a flexibleelastomeric bulb approximately cylindrical in shape with a closed endand an open end. It has a lip around the open end with a comfortablysoft rounded flare to encourage it to seal against the skin with minimalforce and to avoid contact abrasion and the sort of penetrationdiscomfort a narrow edged hard material might cause. The flexiblematerial also allows the user to squeeze the upper end beforeapplication, to encourage formation of a slight vacuum to assist inretaining the device during short intervals such as during cleaning.When a detachable pouch type appliance is used, the narrow size of theStoma Cap allows installation of the replacement adhesive flange,referred to in BACKGROUND OF THE INVENTION, over the top of the StomaCap because the opening in the pouch holder is sized for the stoma andtherefore fits over the Stoma Cap which is approximately the samediameter.

Additionally, the Stoma Cap may include internal absorption materialsuch as cotton wadding or cotton balls to collect effluent and helpavoid spillage upon removal.

Another embodiment of the Stoma Cap may have multi-segment constructionin which each segment is optimized for its function, such as aparticularly soft and flexible sealing lip coupled to a firm body forstructural support, coupled to a deformable section suitable forsqueezing or axial movement useful in creating a vacuum.

Still another embodiment may utilize multiple chambers communicatingthrough check valves such that additional vacuum may be created afterattachment to the patient's skin, in order to restore vacuum lost toleakage or influx of gas from the stoma. Such chambers may be within thesingle piece Stoma Cap device or may be separate and connected throughtubing.

Further features of any of the above embodiments may include sizeadjustment features such as multiple tear-off rings at the open end,each revealing a smaller sealing lip when removed, or a roll-backflexibility which produces a smaller diameter opening as the lip isrolled back due to a substantially conical shape near the open end.Also, the Stoma Cap may be provided in different sizes to fit variousstoma diameters.

Another advantageous feature may be construction such that the Stoma Capis reversible to facilitate internal cleaning.

Still another embodiment may be a Stoma Cap that is a single-use,consumable, disposable element of an ostomy service kit, avoiding theneed for cleaning, inserting absorbent material and subsequent handlingof contaminated absorbent material, and allowing sterile conditions withevery use.

Additionally, adhesive, selected for appropriate removable tackiness andbiological inactivity, may be used to assist sealing and retention ofthe Stoma Cap over the stoma. Such adhesive may be pre-applied to adisposable single-use Stoma Cap device or may be applied prior to use ofa multi-use device.

Additionally, lubricant, such as a bio-inert silicone grease or medicallubricant may be applied to the lip of the Stoma Cap or edge of thestoma region to facilitate superior sealing.

An additional embodiment utilizes the external-only feature of the StomaCap, but does not require flexible vacuum retention; rather it may be ofa substantially firmer construction, may be shorter and contain lessvolume, and may be held in place only by manual pressure or adhesivelip.

An additional embodiment utilizes a durable non-consumable body alongwith consumable disposable inserts containing absorbent material andusing a formable membrane to line the inside of the durable body, formover the lip, and seal to the user's body. This saves sterilizing thedurable body of the Stoma Cap.

An additional embodiment incorporates a double wall such that the vacuumfor retention is presented only along the annular ring of the lipcontact to skin, avoiding applying any vacuum to the stoma itself.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is an oblique view of the Stoma Cap, tipped to allow seeing theabsorbent material inside.

FIG. 2 is an isometric section view showing the Stoma Cap in a useposition over a stoma, with the section cut away to reveal the stoma andthe interior of the Stoma Cap with the absorbent material.

FIG. 3 is a composite perspective view showing how a two-piece ostomypouch appliance would be sequentially assembled, using the Stoma Cap tomaintain cleanliness through the step of attaching the flange to theskin.

FIG. 4 depicts a cross section view of a Stoma Cap with various size liprings which may be removed until a size fitting the particular patientremains.

FIG. 5 depicts a cross section view showing a Stoma Cap with a lip thatcan be rolled back to a smaller diameter of a substantially conicalportion of the body near the lip, allowing size adjustment by suchrollback.

FIG. 6 depicts a cross section view showing a Stoma Cap with twointernal chambers and two check valves, enabling the user to increasethe vacuum by additional pumping after the Stoma Cap is in place.

FIG. 7 shows a variation of the two chamber embodiment, with the pumpingchamber being a separate bulb connected to the body of the Stoma Capwith a tube, and communicating to the Stoma Cap through the tube and twocheck valves, one of which vents to outside air and the other of whichprevents escape of vacuum from the Stoma Cap when the tube is removed.

FIG. 8 shows a Stoma Cap with an inserted replaceable liner containingabsorbent material, the liner folded back over the lip of the Stoma Capand retained by a strengthened edge.

FIG. 9 shows a Stoma Cap designed with an internal passage communicatingthe vacuum chamber to an annular contact area of the lip, isolating thevacuum from the stoma.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the device in more detail, in FIG. 1 there is shown aStoma Cap device 1, typically approximately 5 to 7.5 centimeters (2 to 3inches) long and typically approximately 2.5 centimeters (1 inch) indiameter, although the size may vary to accommodate different types ofsizes of ostomies. It may be fabricated of semi-flexible elastomer suchthat it can be squeezed by finger pressure but naturally spring back tothe shape shown. The lip 3 of the open end of the device is smoothlycurved to prevent abrasive edges contacting the skin and to encouragesealing against the skin. The internal cavity of the device is shown tocontain an amount of absorbent material 2 suitable for absorbingeffluent which may leak from the stoma during the use of this device.

Referring now to the device in more detail, in FIG. 2 there is shown aStoma Cap device 1, which view is sectioned to reveal the interior, in ause position with the lip 3 contacting skin 6 surrounding stoma 5 suchthat leakage from stoma 5 is discouraged from escaping to thesurrounding skin 6 and is encouraged to be absorbed and contained insideStoma Cap 1 by absorbent material 2.

Referring now to the device in more detail, in FIG. 3 there is shown aStoma Cap device 1, which view is sectioned to reveal the interior, in ause position contacting skin 6 surrounding stoma 5 such that leakagefrom stoma 5 is discouraged from escaping to the surrounding skin 6during emplacement of flange 7, which can be slipped over Stoma Cap 1 toadhesively attach to skin 6 without allowing leakage. Subsequently,Stoma Cap 1 can be removed, with spillage discouraged by absorbentmaterial 2 retaining effluent which may have come from stoma 5 duringthe interval of time that Stoma Cap 1 was in place, and pouch 8 can beattached to flange 7.

Referring now to the device in other possible embodiments, in FIGS. 4and 5 can be seen two configurations facilitating adjustment of size ofthe open end of the Stoma Cap 1 to better fit stomas of various sizes.FIG. 4 shows Stoma Cap 1 configured with several size sealing lip rings10, each of which can be removed by tearing off to reveal a smallerring, until appropriate sizing is achieved. FIG. 5 shows an embodimentin which the open end sizing of Stoma Cap 1 is achieved by rolling backthe lip 11 of the body to a smaller diameter region of the body of StomaCap 1, as needed to fit to the patient's stoma.

Referring now to the device as shown in cross section in FIG. 6, with aninternal chamber 16, adjacent the open end of Stoma Cap 1, a secondinternal chamber 15, adjacent the closed end of Stoma Cap 1, a checkvalve 18 allowing passage of gas from chamber 16 to chamber 15 but notin the other direction, and a check valve 19 allowing passage of gasfrom chamber 15 to the ambient outside air, but not in the otherdirection. Squeezing the portion of Stoma Cap 1 in the area of chamber15 forces air out of that chamber through check valve 19 to thesurrounding atmosphere, and releasing that chamber allows it tonaturally expand due to the elastic nature of the material ofconstruction of Stoma Cap 1. In doing so it draws air in from chamber 16due to the action of said check valves, thus improving the vacuum inchamber 16.

Referring to the device as shown in FIG. 7, Stoma Cap 1 forms a firstenclosed chamber when sealed against patient skin, and a squeezable bulb20 forms a second chamber, a check valve 18 allows passage of gas fromStoma Cap 1 to bulb 20 through tube 22 but not in the other direction,and a check valve 19 allows passage of gas from bulb 20 to the ambientoutside air, but not in the other direction. Squeezing bulb 20 forcesair out of that chamber through check valve 19 to the surroundingatmosphere, and releasing that bulb allows it to naturally expand due tothe elastic nature of the material of its construction. With expansionit draws air in from Stoma Cap 1 due to the action of said check valves,thus improving the vacuum in Stoma Cap 1. Tube 22 is additionallydetachable from Stoma Cap 1 or bulb 20 such that flange 7, shown in FIG.3, may be fitted over Stoma Cap 1 as shown in FIG. 3. Check valve 18prevents loss of vacuum upon such detachment of tube 22.

Referring now to the device shown in cross section in FIG. 8, Stoma Cap1 has been additionally fitted with a removable liner 30, folded backover Stoma Cap lip at 31 and substantially retained by strengthened edgerib 32, discouraging accidental separation from Stoma Cap 1. Optionalabsorbent material 2 is shown inside the cavity of the liner which isinside the cavity of Stoma Cap 1. The removable liner 30 and itscontained absorbant material 2 may be provided inexpensively in bulk,sterile, sealed, and ready-to-use packaging, and may be easily disposedof after use. Additional features not shown may include marks on theliner to assist in proper insertion, a flattened feature at lip 31 toimprove sealing, and adhesive or other seal assisting substance appliedto that surface.

Referring now to the device shown in cross section in FIG. 9, Stoma Cap1 is shown constructed with a second internally located wall 35, formingan annular gap 36 at the sealing lip, thus presenting vacuum retentionforce only to the skin surrounding the stoma rather than pulling vacuumfrom the stoma itself. In this embodiment, various material selectionsfor flexibilty of the vacuum chamber 37 and the effluent capture chamber38, may be used to facilitate forming the vacuum in the vacuum chamber37 while not substantially deforming the capture chamber 38.

Any embodiments and variations of the Stoma Cap may be improved with theaddition of adhesive or sealing lubricant to the lip surrounding theopen end, and may benefit from the inclusion of absorbent material 2 asin FIG. 1, FIG. 2, and FIG. 8.

Stoma Caps may also be designed as a consumable disposable item,possibly pre-loaded with absorbent material, prepared with adhesive onthe sealing lip, and requiring no cleaning or sterilizing or handling ofthe contaminated absorbent material.

It is to be understood that the embodiments of the invention hereindescribed are merely illustrative of the application of the principlesof the invention. Reference herein to details of the illustratedembodiments is not intended to limit the scope of the claims, whichthemselves recite those features regarded as essential to the invention.

1. A stoma capping device comprising: a body with a closed end and anopen end, a lip of said open end shaped to encourage forming a sealagainst an approximately flat surface, said lip of said open end furthershaped and smoothed to discourage abrasion to said approximately flatsurface, an opening in said open end sized to surround a stomaconstructed of an ostomy procedure in the skin of a patient, an interiorvolume of said body providing enclosed space suitable for containing avolume of effluent from said stoma, and said interior volume of saidbody also providing enclosed space suitable for containing an absorbentmaterial.
 2. A stoma capping device as in claim 1 wherein some portionof said device is fabricated of a pliable resilient material such that apartial vacuum can be formed by squeezing that portion before sealingthe device to an approximately flat surface.
 3. A stoma capping deviceas in claim 2 wherein said pliable portion of said device is the entirebody of said stoma capping device.
 4. A stoma capping device as in claim1 wherein said lip is fabricated of a pliable material such that animproved seal may be formed to an approximately flat surface.
 5. A stomacapping device as in claim 2 in which said vacuum is applied only aroundthe lip surface by use of annular groove in said lip surface andcommunication path for said partial vacuum from said squeezed portion tosaid annular groove.
 6. A stoma capping device as in claim 1additionally containing absorbent material in the enclosed volume.
 7. Astoma capping device as in claim 1 additionally comprising externalsurface texture features to assist manual gripping.
 8. A stoma cappingdevice as in claim 1 additionally having adhesive pre-applied to saidlip of said open end.
 9. A stoma capping device as in claim 1 whereinsaid open end has more than one sealing lip, the lips being successivelyremovable to reduce the size of said open end.
 10. A stoma cappingdevice as in claim 1 wherein said open end is formed of a rolling edgesuch that rolling the edge in the direction of shortening the stoma capbody reduces the opening size surrounded by the rolling edge.
 11. Astoma capping device as in claim 1 available in various sizes toaccommodate stomas of various diameters.
 12. A stoma capping device asin claim 1 which is further fitted internally with a disposable waterimpermeable liner which: has a closed end inserted substantially intosaid stoma cap cavity, has an open end which may extend beyond the openend of said stoma cap when said closed end is inserted into said stomacap cavity, and may have said extended open end folded back over saidstoma cap sealing lip so as to protect said stoma cap device fromcontact with stoma effluent.
 13. A stoma capping device as in claim 12in which said liner has a rolled or strengthend edge to discouragestretching and thereby provide more secure retention to said stomacapping device when folded back over said stoma cap sealing lip.
 14. Astoma capping device comprising: a body with a closed end and an openend, a lip of said open end shaped to encourage forming a seal againstan approximately flat surface, said lip of said open end further shapedand smoothed to discourage abrasion to said approximately flat surface,an opening in said open end sized to surround a stoma constructed of anostomy procedure in the skin of a patient, an interior volume of saidbody divided into two chambers wherein the first chamber is adjacent theopen end of said body and the second chamber is adjacent the closed endof said body, and wherein passage of air is allowed by a check valve toflow from said first chamber into said second chamber, and passage ofair is allowed by an additional check valve to flow from said secondchamber to the outside air, enabling air to be pumped from said firstchamber through said second chamber to the outside air by action ofsqueezing said second chamber and releasing it to return to anunsqueezed shape, and wherein said first chamber provides enclosed spacesuitable for containing a volume of effluent from said stoma, andwherein said first chamber also provides enclosed space suitable forcontaining an absorbent material.
 15. A stoma capping device as in claim14 in which said first and second chambers are separated by a length oftubing which allows communication of the air flowing from said firstchamber to said second chamber, wherein such second chamber isdetachable from said first chamber by separation of a part of saidlength of tubing.
 16. A stoma capping method comprising placing a stomacapping device over a stoma constructed of an ostomy procedure in theskin of a patient, discouraging effluent from the stoma from reachingthe skin surrounding the stoma during cleaning or ostomy applianceservice wherein such stoma capping method involves covering the stomarather than inserting any object into the stoma.
 17. A stoma cappingmethod as in claim 16 wherein said stoma capping device is retained infunctional position by vacuum, freeing the user to use both hands forother activities.
 18. A stoma capping method as in claim 16 wherein saidstoma capping device is retained in functional position by adhesive,freeing the user to use both hands for other activities.
 19. A stomacapping method as in claim 16 in which a disposable liner is placed atleast partially inside said stoma capping device to preserve thecleanliness of said stoma capping device.
 20. A stoma capping method asin claim 16 in which material to absorb stoma effluent is used insidesaid stoma capping device.